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510(k) Data Aggregation

    K Number
    K250997
    Device Name
    Integrity™ Implant
    Manufacturer
    Anika Therapeutics, Inc.
    Date Cleared
    2025-06-17

    (77 days)

    Product Code
    OWX
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anika Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K231968
    Device Name
    Tactoset® Injectable Bone Substitute
    Manufacturer
    Anika Therapeutics, Inc.
    Date Cleared
    2023-12-20

    (170 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anika Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tactoset® Injectable Bone Substitute is a synthetic, biocompatible material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgicallycreated osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, selfsetting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process. Tactoset® Injectable Bone Substitute can augment hardware and support bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.
    Device Description
    Tactoset® Injectable Bone Substitute is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution in separate pre-loaded syringes) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PO4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7], hyaluronic acid (HA), Iohexol (C19H26J3N309) and water for injection. Tactoset is provided sterile for single use.
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    K Number
    K223538
    Device Name
    Integrity Implant
    Manufacturer
    Anika Therapeutics, Inc.
    Date Cleared
    2023-08-17

    (267 days)

    Product Code
    OWX
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anika Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Integrity Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
    Device Description
    The Integrity Implant is a partially resorbable mesh. The Integrity Implant is designed to provide an augmentation layer over an injured tendon. The patch is comprised of a knitted porous mesh of resorbable Hyaff multifilament fibers and non-resorbable poly(ethylene terephthalate) [PET] multifilament fibers. The patch is provided sterile, for single use only, in a variety of sizes in a thermoformed tray with peelable lid and outer polymer packaging. The device is an easy-to-handle, pliable, nonfriable, porous patch in both the dry and hydrated state. The Integrity Implant will be made available in 2 sizes: - 20mm X 25mm - 25mm X 30mm The mechanism of action of the Integrity Implant is to function as a protective layer by keeping damaged tendon physically separated from surrounding tissues during healing. It is not intended to replace substantial loss of tendon. Over the course of 4-6 months, the device will be mostly resorbed by the body. The patch will be used in a surgical environment by a board-certified surgeon. It will be implanted using a standard open or arthroscopic access surgical procedure. It will be fixated at one end to the bone via fixation anchor and at the other end to the repaired tendon via suture or fixation anchor.
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    K Number
    K222487
    Device Name
    Anika Tissue Tack Fixation System
    Manufacturer
    Anika Therapeutics, Inc.
    Date Cleared
    2023-05-08

    (264 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anika Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Anika Tissue Tack is indicated for the fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures, such as rotator cuff repair.
    Device Description
    The Anika Tissue Tack Fixation System consists of dart shaped tacks and a delivery instrument. The tissue tacks are comprised of bioabsorbable 82/18 poly(lactic-co-glycolic acid) [PLGA] and dyed with D&C Violet #2. The tissue tacks are designed to provide stable fixation of a prosthetic material or biologics to soft tissues during the healing process and are used in conjunction with a delivery instrument from Anika. The delivery instruments are comprised of surgical grade stainless steels and high temperature plastics and are designed to deliver the tissue tacks. The tissue tacks and delivery instruments are provided sterile for single use only. The tacks are packaged in a caddy within a dual sterile seal configuration.
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    K Number
    K190956
    Device Name
    SCS 17-01
    Manufacturer
    Anika Therapeutics, Inc.
    Date Cleared
    2020-01-30

    (294 days)

    Product Code
    MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anika Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SCS 17-01 is a syntheic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the skeletal system (i.e. extremites and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.
    Device Description
    The SCS 17-01 product is a synthetic, injectable, settable osteoconductive calcium phosphate bone graft substitute material. SCS 17-01 is composed of a dry powder and an aqueous solution (supplied in separate sterile, preloaded syringes) that must be mixed intra-operatively to form a cohesive paste prior to implantation using the supplied mixing system. The dry powder is composed of the alpha phase of tricalcium phosphate (alphaTCP) [Ca3(PO4)2], calcium [CaCO3] carbonate phosphate [Ca(H2PO4)2]. The aqueous component is composed of water for injection, sodium phosphate dibasic [Na2HPO4], citric acid [C6H8O7] and hyaluronic acid (HA). Upon mixing the cement powder and the setting solution at body temperature, a dissolution and reprecipitation reaction occurs resulting in the precipitation of a poorly crystalline hydroxyapatite. During the healing process, the bone void filler resorbs and is replaced with new bone growth. SCS 17-01 is provided sterile for single use in volumes ranging from 1cc to 4cc.
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    K Number
    K173008
    Device Name
    SCS 17-01
    Manufacturer
    Anika Therapeutics, Inc.
    Date Cleared
    2017-12-26

    (90 days)

    Product Code
    MQV, MOV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    Anika Therapeutics, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SCS 17-01 is a synthetic, biocompatible bone graft substitute material that hardens and converts to a poorly crystalline hydroxyapatite at body temperature. It is indicated for filling bone voids or defects of the sketal system (i.e. extremities and pelvis) that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The device provides an injectable, self-setting, osteoconductive bone graft substitute that resorbs and is replaced by the growth of new bone during the healing process.
    Device Description
    SCS 17-01 is an injectable, settable osteoconductive calcium phosphate bone graft substitute material. It is provided to the end-user as two components (a dry powder and an aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a cohesive paste. The dry powder component is composed of the alpha phase of tricalcium phosphate [Ca3(PO4)2], calcium carbonate [CaCO3], and monocalcium phosphate [Ca(H2PQ4)2]. The liquid component is composed of sodium phosphate dibasic [Na2HPO4], citric acid [CoH30], hyaluronic acid (HA), and water for injection. SCS 17-01 is provided sterile for single use in volumes ranging from 1.5cc to 4cc and is provided in a kit containing the dry powder component and the liquid component in pre-loaded syringes.
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